BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACH TUBE HOLDER

    MDR report key: 21753152 · Received April 2, 2025

    Report

    Report Number
    3003753847-2025-00001
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    March 11, 2025
    Report Date
    April 15, 2025
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    CBH
    PMA / PMN Number
    K922657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION. (B)(4) IS THE INITIAL IMPORTER AND DISTRIBUTOR OF THE MEDICAL DEVICE. THE PRODUCT IS SUPPLIED BY (B)(4)., (FDA REGISTRATION NUMBER 2529776). A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) WAS ISSUED ON MARCH 13, 2025. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. THE SUPPLIER REVIEWED SAMPLES FROM ALL CURRENT INVENTORY IN WAREHOUSE AND NOTED ALL PRODUCT WAS MADE TO SPECIFICATION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NOTED PRODUCT MANUFACTURED RECENTLY MATCHED THE APPROVED FIRST ARTICLES. NO CHANGES HAVE BEEN MADE TO ANY MATERIALS USED IN PRODUCTION SINCE THIS PRODUCT WAS LAUNCHED. A ROOT CAUSE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER, PHOTO OR FURTHER INFORMATION ON THE EVENT. SITE ASKED ADDITIONAL INCIDENT QUESTIONS ON (B)(6) 2025. THE CUSTOMER HAS NOT RESPONDED TO-DATE. THIS IS CONSIDERED AN ISOLATED EVENT AS THERE ARE NO OTHER COMPLAINTS REPORTED CONCERNING THE QUALITY OF THE PRODUCT. WE WILL CONTINUE TO MONITOR COMPLAINTS TO IDENTIFY ANY EMERGING TRENDS OR NEEDS TO IMPLEMENT CORRECTIVE ACTION(S). THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE VELCRO ON THE SIDE OF THE NECK COMES LOOSE EASILY. A PATIENT'S TRACH TUBE BECAME DISLODGED. RESPIRATORY THERAPIST REMOVED THE TUBE AND IMMEDIATELY REPLACED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371469 TRACH TUBE HOLDER ADULT TRACH TUBE HOLDER CBH OWENS & MINOR DISTRIBUTION, INC. TTH1001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other